Powered by OpenAIRE graph
Found an issue? Give us feedback
addClaim

Identification of Common Data Elements from Pivotal FDA Trials.

Authors: Craig S. Mayer; Nick Williams; Vojtech Huser;

Identification of Common Data Elements from Pivotal FDA Trials.

Abstract

It is difficult to arrive at an efficient and widely acceptable set of common data elements (CDEs). Trial outcomes, as defined in a clinical trial registry, offer a large set of elements to analyze. However, all clinical trial outcomes is an overwhelming amount of information. One way to reduce this amount of data to a usable volume is to only use a subset of trials. Our method uses a subset of trials by considering trials that support drug approval (pivotal trials) by Food and Drug Administration. We identified a set of pivotal trials from FDA drug approval documents and used primary outcomes data for these trials to identify a set of important CDEs. We identified 76 CDEs out of a set of 172 data elements from 192 pivotal trials for 100 drugs. This set of CDEs, grouped by medical condition, can be considered as containing the most significant data elements.

Keywords

Clinical Trials as Topic, Common Data Elements, Pharmaceutical Preparations, Research Design, United States Food and Drug Administration, Humans, Drug Approval, United States

  • BIP!
    Impact byBIP!
    selected citations
    These citations are derived from selected sources.
    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    0
    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Average
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Average
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Average
Powered by OpenAIRE graph
Found an issue? Give us feedback
selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average
Related to Research communities
Upload OA version
Are you the author of this publication? Upload your Open Access version to Zenodo!
It’s fast and easy, just two clicks!